臨床研究等提出・公開システム

A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)

A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric)

Myoishi Masafumi

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

byl_ct_contact@bayer.com

Dedicated contact

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

+81-6-6133-6363

byl_ct_contact@bayer.com

Complete

Aug. 21, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

- Participants from birth to <18 years of age at the time of signing the informed consent form.
- Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement.
- Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement).
- Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations.
- The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits.

- Body weight <2500 g at screening and baseline
- The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including pharmacokinetics (PK) and safety blood draws, without compromising any expected clinical care/procedure need.
- Acute kidney injury (i.e., acute renal failure).
- Age-adjusted renal function is decreased (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum creatinine result obtained within 2 weeks prior to study intervention.
- Considered clinically unstable or has a concurrent/concomitant condition that may not allow participation for the full planned study period, in the judgement of the investigator.
- History of moderate to severe allergic-like reaction to any GBCA.
- Bronchial asthma considered unstable or had major therapeutical modification within last 4 weeks.
- Severe cardiovascular disease, except for cardiac or vascular magnetic resonance (MR), if considered clinically justified by the investigator.
- Planned or expected intervention (e.g., treatment or procedure) or change in treatment (e.g. start of chemotherapy) that may significantly affect study parameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters) or would prevent the participant from performing study procedures, from the administration of gadoquatrane up to the 24 h +- 4 h follow-up.
- Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection.
- Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs.

Both

pediatric participants (from birth to <18 years) undergoing contrast-enhanced MRI

- Drug: Gadoquatrane (BAY1747846)
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

1. Area under the curve (AUC) of gadoquatrane after single administration
2. Plasma clearance normalized to body weight (CL/BW) of gadoquatrane after single administration
3. Apparent volume of distribution at steady state normalized to body weight (Vss/BW) of BAY1747846 after single administration
4. Simulation of plasma concentration at 20 min post-injection (C20)

+81-11-716-1161

June. 29, 2023

No

United States/Argentina/Belgium/Bulgaria/Canada/China/Czechia/Germany/Hungary/Poland/Sweden